At Archimedic, we were working with a client to bring their tissue storage device through the stages of development to get FDA approval. During my time at Archimedic, this project was mostly focused on pre-V&V testing in the design and development stage.
I inspected parts that we received from various manufacturers to ensure that they were compliant with our quality standards. Once all of the parts were inspected, I completed three different builds in a clean room for a total of 100 devices. We sent 60 devices to the client, and I performed engineering verification testing on the remaining devices. Some tests that I performed were drop testing, leak testing, ink adhesion testing, torque testing, and volume testing. For tests that did not pass, I worked with my supervisor to conduct root cause analysis, and took appropriate actions to ensure future devices would not fail. After the testing was complete, I wrote several reports about my findings and confirmed that the project was ready to move into formal verification and validation testing.
The project was able to move beyond the design and development stage into formal V&V testing.
